Pharmabiz
 

STORAGE RULES FOR DRUGS

P A FrancisThursday, May 12, 2016, 08:00 Hrs  [IST]

Sudden rise in temperature in almost all parts of the country this year is causing serious concern to the health authorities and people of the country with emergence of various diseases especially among the poor. This climatic change is stated to be on account of increased and uncontrolled carbon emissions into the atmosphere and high air pollution levels in cities and urban areas. To effectively tackle this dangerous climatic change, all the regulatory authorities in the country will have to jointly work with appropriate solutions. Even then an instant reduction in the heat condition should not be expected in the near future. Considering this grave reality, the health authorities have to act on what is immediately possible from their side to address this situation. The need to store drugs and pharmaceuticals in right temperature conditions to maintain their potency and efficacy is probably one such measure to be introduced immediately. Of the 7 lakh retail chemists in the country, hardly one per cent of them are having air conditioned premises to keep the stocks of medicines as of today. When the heat conditions worsen in months of May and June one can imagine what could be quality of drugs stored and sold in medicine shops of most of the states. In many locations in the country day temperature is already ranging between 30 and 42 degree centigrade.  

Most of the antibiotics have to be kept in a cool and dry place with temperature ranging between 10-25 degree centigrade. And almost all life saving injections and vaccines for BCG, cholera, measles, plague and polio need to be stored in a cool place and protected from direct sunlight. Even analgesics have to be stored and transported in prescribed temperature conditions to maintain their potency throughout their shelf life. The need for proper storage of drugs starts from the manufacturing sites where godowns of pharmaceutical companies are usually situated. The quality of drugs can get seriously affected even during the transportation from the factory to C&F agents, wholesalers and finally to retailers if they are carried in open vehicles exposed to sunlight and humid weather. Constant exposure to temperatures above 30 degree centigrade for a few days can substantially degrade the antibiotics and vitamins. The Karnataka State Registered Pharmacists Association’s initiative, in this context, to approach the state government urging it to make mandatory to have an air conditioned space in all the medical stores in state is a welcome move. The Association sought an amendment to the Drugs & Cosmetic Rules under Rule 64 making it compulsory for every chemists & druggists to install an air conditioner in their premises before new licenses are issued. For the old license holders, the state regulator should insist on installation of air conditioner unit at the time of renewal. These conditions need to be made mandatory all over the country. In fact, there was a move on the part of the Union health ministry in early 2014 to amend the D & C Rules for regulating transportation and storage of drugs in the country with the same objective of protecting shelf lives of drugs. But, no further steps have been taken by the ministry since then.

 
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